Safety notes
4 M320 Ref. 10734261 / Version 03 M320 Ref. 10734261 / Version 03 5
3 Safety notes
The Leica M320 surgical microscope is state-of-the-art technology.
Nevertheless, hazards can arise during operation. Always follow the
instructions in this user manual, and in particular the safety notes.
3.1 Intended use
• The Leica M320 surgical microscope is an optical instrument for
improving the visibility of objects through magnification and
illumination. It can be applied for observation and
documentation and for human and veterinary medical
treatment.
• The Leica M320 surgical microscope is subject to special
precautionary measures for electromagnetic compatibility.
• Portable and mobile as well as stationary RF communications
equipment can have a negative effect on the reliability of the
Leica M320 surgical microscope's functionality.
• The Leica M320 is intended for professional use only.
3.2 Indications for use
• The Leica M320 surgical microscope is suitable for surgical
applications such as ENT and dental sugeries in hospitals, clinics
or other human medical institutions.
• The Leica M320 surgical microscope may only be used in closed
rooms and must be placed on a solid floor or mounted to the
ceiling.
• This User Manual is intended for physicians, nurses and other
medical and technical staff who prepare, operate or maintain
the device after appropriate training. It is the duty of the device
owner / operator to train and brief all the operating personnel.
3.3 Contraindications
Not for use in ophthalmology.
3.4 Information for the person
responsible for the instrument
X The surgical microscope may be used by qualified and trained
users only, with all covers fitted.
X Only use the surgical microscope if it is free of defects.
X Operate the system only with all equipment in its proper
position (e.g. all covers fitted, doors closed).
X Regularly check to make sure the users are complying with
safety requirements.
X Provide comprehensive instructions and explain the warning
messages.
X Assign and monitor responsibilities for commissioning,
operating and maintenance.
X Use the surgical microscope in proper condition only.
X Do not place the drape too close to the instrument, as otherwise
it can overheat and shut off.
X Inform your Leica representative or Leica Microsystems
(Schweiz) AG immediately if you detect a product defect that
could potentially cause injury or harm.
X Only the following accessories may be used with the surgical
microscope.
X Leica Microsystems accessories described in this user manual.
X Other accessories, provided that these have been expressly
approved by Leica as being technically safe in the context.
X Use original accessories or approved Leica accessories only.
X Use only high-quality HDMI cables with a maximum length of
10 m.
X Use only monitors approved for medical purposes or equipped
with an isolating transformer.
X Modifications or repairs may be carried out by authorized
trained personnel only.
X Use only original Leica parts in maintenance work.
X After maintenance or technical modifications, readjust the
instrument in accordance with our technical specifications.
X If the instrument is modified by or maintenance has been
performed by unauthorized personnel, if the equipment is
improperly maintained or if the instrument has been operated
improperly, Leica disclaims all liability.
X The owner or operator shall be held liable for the function of the
system if the system has been assembled incorrectly by
individuals who do not belong to Leica Microsystems (Schweiz)
AG.
X The influence on other devices by the Leica M320 surgical
microscope has been tested in accordance with EN 60601-1-2.
The system passed the emissions and immunity test. The
standard preventive measures and safety regulations pertaining
to electromagnetic and other radiation have to be observed.
X Only the supplied power cord may be used.
